Before an autologous HCT product can be administered to a patient, a medical or dental professional needs to assess whether the therapeutic good is appropriate and suitable for that patient.
Advertising that encourages consumers to seek out such treatments prior to such an assessment may undermine the ‘medical or dental practitioner-patient’ relationship and is prohibited under the Therapeutic Goods Act 1989 (the Act).
The TGA regulates HCT products and is responsible for administering the Act and the Code, which specify requirements and prohibitions relating to the advertising of therapeutic goods.
The TGA may pursue sanctions and penalties against those who do not comply with the advertising and other applicable regulatory requirements.
Human cell and tissue (HCT) products are those that comprise, contain or are derived from human cells and tissues.
Autologous human cell and tissue products
Autologous human cell and tissue (HCT) products are those that are removed from, and applied to, the same person, i.e. the donor and the recipient are the same. These include some products commonly referred to as ‘stem cell treatments’.
Examples of autologous human cell and tissue products
Examples of autologous HCT products that this guidance applies to include…
Most of these HCT products would be regulated as biologicals under the biological regulatory framework, except blood components.
Advertising of services is permitted
Services (that do not mention specific products) are permitted to be advertised. However, the advertisement must comply with…
Promoting your health service or business
It is possible to promote health services involving HCT products. However, to ensure such promotion does not additionally illegally advertise a therapeutic good, an advertiser must not refer, either overtly or by implication, to HCT products.
This includes making references through:
Compliance with the therapeutic goods legislation
An advertisement for a health service that specifies the use of any autologous HCT product associated with that service is not permitted as it would promote the product also.
These requirements apply to health professionals and professional bodies.
The requirements apply to all forms of media, including traditional media (such as television, radio, print media and posters/displays) and electronic media (such as websites, emails, blogs, discussion forums and social media).
Penalties for non-compliance
In the first instance, the TGA seeks to inform, educate and assist advertisers to comply with the rules relating to advertising. However, if this approach fails, we may take further action to achieve compliance.
The Act provides for financial penalties for advertising breaches. Fines for such offences can be up to $840,000 for individuals and up to $4,200,000 for corporations.